聚山梨酯80及其杂质的研究进展

Research advances of polysorbate 80 and its impurities

目的归纳总结聚山梨酯80的杂质种类、含量测定及检查方法,为寻找含聚山梨酯80注射剂,特别是含该辅料中药注射剂发生(类)变态反应的物质基础提供参考。方法查阅并总结资料文献,对国内外聚山梨酯80的研究进行综述。结果聚山梨酯80除含有符合结构通式的成分外,还含有简单小分子类、脂肪酸类、酯类和醚类等杂质,并可能含有以前忽视的大分子杂质。结论各类杂质,特别是大分子杂质可能是导致含聚山梨酯80注射剂发生(类)变态反应的物质基础。

Objective To summarize the impurities,inspection and determination methods of polysorbate 80,and find out the relationship between impurities and anaphylactic or anaphylactoid reactions of injections(especially traditional Chinese medicine injections)containing polysorbate 80.Methods By reviewing and summarizing the data and literature,the literature of research and review on polysorbate 80 were summarized.Results Besides components consistent with the general structural formula,polysorbate 80 contains numerous impurities that can be grouped into simple small molecules,fatty acids,esters and ethers.Furthermore,polysorbate 80 likely contains macromolecular components.Conclusion The impurities,especially macromolecular impurities in polysorbate 80 are likely the material basis for anaphylactic or anaphylactoid reactions of injections containing the excipient.